Resistance Exercise Effects on Fear Avoidance and Physical Function in Obese Older Adults With Low Back Pain
2014年2月12日 更新者：University of Florida
Resistance Exercise Effects on Fear Avoidance Beliefs and Physical Function in Obese, Older Adults With Chronic Low Back Pain
The purpose of this study is to determine if a 4 month resistance exercise program reduces the severity of low back pain, pain-related fear avoidance and improves mobility compared to standard care.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
72
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Florida
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Gainesville、Florida、美国、32607
- UF&Shands Orthopaedics and Sports Medicine Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- chronic low back pain for >6 months
- >3 pain episodes per week
- waist circumferences ≥102 cm for men
- waist circumferences ≥ 88 cm for women
- willing and able to participate in regular exercise for 14 weeks
- using pain medications to control low back pain
- free of abnormal cardiovascular responses during a screening graded maximal walk test
Exclusion Criteria:
- unable to walk
- participating in regular resistance exercise training (>3X week) in the past 6 months
- pain symptoms are too severe and prevent strength testing or walking
- acute back injury
- spinal stenosis that precludes walking one block due to neurogenic claudication
- back surgery within the past 2 years
- current use of weight loss interventions (drugs; exercise interventions)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Standard care
Subjects will receive normal medical care and follow up during the four month study period if assigned to this group.
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physical activity/ nutrition guidelines will be provided and reviewed with the participant as part of standard care; telephone contact will be made weekly to encourage adherence to the health guidelines
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有源比较器：Isolated Lumbar Resistance Exercise Program
Lumbar extension exercise protocol to increase strength and reduce pain.
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lumbar extension, two set of 10-15 repetitions, once a week for two weeks; lumbar extension, one set of 10-15 repetitions, three times a week, week 3 to 4 months
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有源比较器：Total Body Resistance Exercise Program
Training protocol for 1 set for each exercise: leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, calf press and abdominal curl
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exercises: leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, calf press and abdominal curl, one set of 10-12 repetitions, three time per week, week one to 4 months
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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10 centimeter Visual Analog Scale (VAS); Change from Baseline at 1, 2, 3 and 4 Months
大体时间：Baseline, 1, 2, 3 and 4 Months
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The VAS scale will range from 0-10 cm, where a rating of "0" reflects no pain, and a "10" rating represents "worst pain imaginable.
Subjects will complete the VAS at the indicated time intervals to document any change in their pain levels.
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Baseline, 1, 2, 3 and 4 Months
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Tampa Scale of Kinesiophobia (TSK); Change from Baseline at 1, 2, 3 and 4 Months
大体时间：Baseline, 1, 2, 3 and 4 Months
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Fear avoidance beliefs will be measured using the 11 item TSK.
Subjects will complete the TSK at the indicated time intervals to document any change in their fear avoidance beliefs.
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Baseline, 1, 2, 3 and 4 Months
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Fear-Avoidance Beliefs Questionnaire (FABQ); Change from Baseline at 1, 2, 3 and 4 Months
大体时间：Baselinje, 1, 2, 3 and 4 Months
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The FABQ is a tool based on theories of fear and avoidance behavior and focuses specifically on beliefs about how physical activity and work affect low back pain.
Subjects will complete the FABQ at the indicated time intervals to document any change in their fear and avoidance behavior.
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Baselinje, 1, 2, 3 and 4 Months
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Pain Catastrophizing Scale (PCS); Change from Baseline at 1, 2, 3 and 4 Months
大体时间：Baseline, 1, 2, 3 and 4 Months
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The PCS will be used to assess the effect of the chronic back pain on rumination on pain symptoms and helplessness.
Subjects will complete the PCS at the indicated time intervals to document any change in their thoughts of their pain symptoms.
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Baseline, 1, 2, 3 and 4 Months
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Modified Oswestry Disability Index (ODI); Change from Baseline at 1, 2, 3 and 4 Months
大体时间：Baseline, 1, 2, 3 and 4 Months
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The ODI is responsive to intervention treatments for low back pain, is reliable, and corresponds well with several global patient disability measures.
Subjects will complete the ODI at the indicated time intervals to document any change in their low back pain.
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Baseline, 1, 2, 3 and 4 Months
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Roland Disability Survey (RDS); Change from Baseline at 1, 2, 3 and 4 Months
大体时间：Baseline, 1, 2, 3, and 4 Months
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The RDS assesses physical disability and mental function with low back pain; this survey is sensitive to treatment interventions, and is reproducible and consistent and correlated well with other global ratings and disability measures.
Subjects will complete the RDS at the indicated time intervals to document any change in their physical disability and mental function with their low back pain.
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Baseline, 1, 2, 3, and 4 Months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Graded Treadmill Exercise Test; Change from Baseline at 4 Months
大体时间：Baseline and 4 Months
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Maximal aerobic fitness, or oxygen consumption (VO2max) will be determined using a walking symptom-limited graded exercise test.
Subjects will complete the exercise test at the indicated time intervals to document any change in their aerobic fitness.
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Baseline and 4 Months
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Chair Rise Time, Stair Climb Time and Gait Assessment; Change from Baseline at 4 Months
大体时间：Baseline and 4 Months
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Chair rise time will be measured as the participant moves from a sitting to a full standing position.
The time to walk up one flight of stairs will be measured by having the participants walk up one flight of stairs consisting of 12 steps as quickly as possible.
Gait will be assessed by having the participants walk across a 26' portable walkway.
Subjects will complete these motions at the indicated time intervals to document any change.
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Baseline and 4 Months
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7-day Pedometer Test; Change from Baseline at 4 Months
大体时间：7 day period at Baseline and 4 Months
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Community ambulation will be estimated using a 7-day pedometer test in which participants will wear a StepWatch® step activity monitor.
Subjects will complete this test at the indicated time intervals to document any change in their ambulation.
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7 day period at Baseline and 4 Months
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Ultrasound Muscle Thickness; Change from Baseline at 4 Months
大体时间：Baseline and 4 Months
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The ultrasound technique that will be used to capture muscle thickness changes in the paraspinal and multifidus muscles.
Subjects will be tested at the indicated time intervals to document any change.
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Baseline and 4 Months
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Muscle Strength; Change from Baseline at 1, 2, 3 and 4 Months
大体时间：Baseline, 1, 2, 3 and 4 Months
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Assessments of strength (1 repetition maximum, 1-RM) will be determined for all muscle groups trained.
Subjects will be assessed at the indicated time intervals to document any change.
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Baseline, 1, 2, 3 and 4 Months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年11月1日
初级完成 (实际的)
2014年2月1日
研究完成 (实际的)
2014年2月1日
研究注册日期
首次提交
2010年11月5日
首先提交符合 QC 标准的
2010年11月29日
首次发布 (估计)
2010年11月30日
研究记录更新
最后更新发布 (估计)
2014年2月14日
上次提交的符合 QC 标准的更新
2014年2月12日
最后验证
2014年2月1日
更多信息
与本研究相关的术语
其他研究编号
- 258-2010
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